Diet Aids and FDA Approval

The diet industry is huge, a multimillion dollar industry. The introduction to products that help individuals lose weight will always be popular and interest never wanes because of the frequency in which new products arise from the market. Now comes the big question, just how important is it for diet aids to have Food & Drug Agency (FDA) claims? Most health supplements, vitamin supplements, and diet aids do not have FDA approved on them. But does this really matter? In some cases, yes and in others no. The FDA is an organization that is part of the US department of Health and Human Services.

The center for drug evaluation and research (CDER) makes sure that all prescription and over the counter drugs are safe for consumers, including diet supplements. Most diet aides are released without being regulated from the FDA but every now and then one is, the most recent being ephedra, and its ban. It is important to remember two things when reading claims whether they are for health benefits or for dangerous side effects. The first is that if there is a warning on the label it is unknown whether 50% of all those that used the product or if on 0.

1% had side effects. Companies must put the side effect warning on the label if only one person in the study had side effects. This is mainly for insurance, if you take the diet aid and experiences side effects out of thousands of individuals that don’t then you can’t sue the company; the warning was on the label. Secondly just because there are health benefit claims on the label doesn’t actually mean that they will happen to the individual taking the product. It simple means that it may happen not that it definitely will.

However having FDA approval is always a good thing. Unlike a company the FDA will conduct research or contract researchers to conduct a thorough and correctly structured clinical study. Any results will show good conclusions that can be trusted. The FDA is looking out for the consumer, not the companies whose bottom line is to make as much product as possible. Here is an outline of the regulation of diet aids with ephedra. Ephedra was a popular weight loss product, particularly when paired with caffeine and aspirin.

However the use of ephedra was linked to heart problems and over 155 deaths. Like many diet aids it increases your metabolism by increasing your heart rate, which causes many problems. The FDA could not actually ban ephedra but it sent out a ruling that the FDA does not support and products containing ephedra as it had unreasonable risks of illness or death associated with it. The FDA collected information about ephedra from independent experts and studies on both the benefits and dangers of ephedra.

However it should be noted that Chinese herbal medicines and teas that contain ephedra are not regulated under this ruling. (Nelson, 135). Now it is very likely that a vast majority of individuals using ephedra did not experience any side effects or heart problems at all. However there was enough of the population that did, and most importantly quite a few deaths were found to be directly linked to ephedra in diet supplements that the FDA felt there was a significant cause for concern.

Due to it’s ruling many states in the US banned the selling of ephedra products causing many companies to reformulate their diet products. Also if you look at the history of the FDA and its rulings you will find a very tangled web. The FDA during the 1940s and 50s in diet aids approved amphetamines and amphetamine like products. Since then the FDA has been trying to define the parameters in which these products can be safely taken (Colman, 380-385). The FDA has been found to change its mind over time, particularly as science is improving and research tools are becoming available.

Now I should let you know that a product containing ephedra is still all-natural because ephedra comes from the Ma Huang plants. Incidentally most health supplements and diet aids all come from plants, so they are “all natural”. Just because it is labeled all natural doesn’t mean it isn’t dangerous. Almost anything at the wrong level will kill you. It is simply the products that are dangerous at small amounts that cause the most concern. Eating carrots can cause blindness and eventually death, but you have to eat a lot of carrots for a long time.

Many of the substances found in diet aids are at concentration higher than they would be found in nature and this is what can make them harmful. Now comes the consumer, just who should they believe. You are standing in a store reading a label that lists some pretty fantastic benefits, but it is not FDA approved (Allen). Many products are being marketed as helping you lose weight, improve your life p or have anti-aging properties. Without the correct clinical trials, which can take years, it is unknown if the benefits outweigh the risks.

As previously stated Ephedra was first approved and then found to be dangerous as was another product called Fen-phen. (Keim). There are many health claims available to help your memory, expand your age, make your heart healthier etc. You can achieve this by taking ginkgo boloba, cinnamon extract, grapefruit extract, acai juice, resveratrol etc. There are other diet aids that act as appetite suppressants or are thermogentic (raise your metabolism), fat blockers, and meal replacement.

The real danger is not using the diet aids in a correct manner as there are significant risks of developing eating disorders when using dieting aid (Celio, 492-497). This takes away from the benefits you will have by losing weight because you will be lighter but you won’t be healthy. It is amusing to actually read the directions on diet aids. The majority of the time the directions give dosage information and then state that it is only effective eating a healthy diet and exercise. Now most medicinal practitioners and athletes can get an individual to lose weight by eating sensible and exercising.

The diet aid may actually work not because of the diet aid but because you are eating a healthy diet and exercising. There is a large psychological part to dieting that many people do not understand. On a personal note I would feel much more secure and confident using a diet aid that was approved by the FDA but that does not mean that I would rule out using other products. I would first research and collect some information about products. I would stear clear of any product that says has side effects relating to heart problems or internal organ failure.

If the side effects are not minor and research shows that cultures have been using it successfully for years then I probably would try it. It is important to pay attention to detail such as concentration in the diet aid as well as follow the directions and pay attention to what is going on in your body. If I had any concerns I would see about speaking to a nutritionist or doctor about any risks. It is fine to use diet aids but don’t just pick one on a whim. You do need to be careful and determine what the risks are and if you think the benefits are greater than the risks.